Peptide Graded

Cagrilintide

Does Cagrilintide work?

Partly: some human trials, with gaps. The main trial of the drug alone had 706 people.

BSome human evidenceIn clinical trialsas of 2026-10-27

For weight loss, cagrilintide alone has a 906-participant randomized phase 2 dose-finding trial, 706 of them on cagrilintide, and a 96-participant phase 1b combination trial; the 3,417-participant REDEFINE 1 phase 3 trial tested it mainly in combination with semaglutide, with a 302-person cagrilintide-alone arm. Randomized trials exist but the standalone drug has no completed phase 3 and no approval, which is grade B. A 2026 meta-analysis of six CagriSema trials in diabetes (4,554 participants) adds to the combination evidence, not to the standalone case. 781116

The phase 2 dose-finding trial was published in The Lancet in 2021. It randomized 906 adults with overweight or obesity and no diabetes. Of those, 706 got one of five weekly cagrilintide doses, 99 got daily liraglutide and 101 got placebo, for 26 weeks. Weight fell by 6.0% to 10.8% across the cagrilintide doses. It fell 3.0% with placebo. The highest dose beat liraglutide. Dropout was similar across groups. 7

REDEFINE 1 was a 68-week phase 3 trial published in the New England Journal of Medicine in 2025. It randomized 3,417 adults with obesity or overweight plus a complication. They got CagriSema, semaglutide alone, cagrilintide alone or placebo. Weight fell 20.4% with CagriSema versus 3.0% with placebo. More people on the combination lost 20%, 25% and 30% of their weight than on placebo. For comparison, semaglutide alone produced 14.9% weight loss at 68 weeks in STEP 1 (1,961 participants). Tirzepatide at its highest dose produced 20.9% at 72 weeks in SURMOUNT-1 (2,539 participants). 8910

Evidence checklist

  • Randomised controlled trial 706-person phase 2; REDEFINE 1 phase 3
  • Human study over 100 people REDEFINE 1, 3,417 adults (mostly combination)
  • More than one research group Trials appear to be from the maker; not stated
  • Clinical outcomes, not surrogate markers Weight change, not heart or other outcomes
  • Human safety data beyond case reports Trial data to 68 weeks; GI effects common

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More on Cagrilintide

Citations

  1. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 dose-finding trial (DOI) doi.org
  2. StatPearls: Glucagon-like peptide-1 receptor agonists and the incretin system ncbi.nlm.nih.gov
  3. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide (REDEFINE 1) (DOI) doi.org
  4. ClinicalTrials.gov: standalone phase 3 trial of cagrilintide clinicaltrials.gov
  5. FDA: concerns with unapproved GLP-1 drugs used for weight loss fda.gov
  6. DailyMed: Symlin (pramlintide) label dailymed.nlm.nih.gov
  7. Lau 2021, Lancet: once-weekly cagrilintide for weight management, phase 2 trial pubmed.ncbi.nlm.nih.gov
  8. Garvey 2025, NEJM: coadministered cagrilintide and semaglutide in adults with overweight or obesity (REDEFINE 1) pubmed.ncbi.nlm.nih.gov
  9. Wilding 2021, NEJM: once-weekly semaglutide in adults with overweight or obesity (STEP 1) pubmed.ncbi.nlm.nih.gov
  10. Jastreboff 2022, NEJM: tirzepatide once weekly for the treatment of obesity (SURMOUNT-1) pubmed.ncbi.nlm.nih.gov
  11. Enebo 2021, Lancet: cagrilintide with semaglutide, phase 1b trial pubmed.ncbi.nlm.nih.gov
  12. Lancet 2025: amycretin, a unimolecular GLP-1 and amylin receptor agonist, phase 1b/2a pubmed.ncbi.nlm.nih.gov
  13. Diabetes Obes Metab 2024: cagrilintide thorough QT study pubmed.ncbi.nlm.nih.gov
  14. Lancet 2025: eloralintide, a selective amylin receptor agonist, phase 2 trial pubmed.ncbi.nlm.nih.gov
  15. Novo Nordisk Q4 2025 report (SEC filing): CagriSema submitted to the FDA sec.gov
  16. Kow 2026, Diabetes Obes Metab: efficacy and safety of CagriSema in type 2 diabetes, systematic review and Bayesian meta-analysis pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Cagrilintide article, fact-checked against the cited sources. No dosing anywhere on this site.